Nissen Sleeve by Single Port With Magnetic Assistance | NCT04931706

Studies
Nissen Sleeve by Single Port With Magnetic Assistance

NCT04931706

Sponsor

Unidad Internacional de Cirugia Bariatrica y Metabolica

Status

Unknown status

Last Update Posted

Jun 18, 2021Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Bariatric Surgery Candidate
Obesity
GERD

Interventions

Magnetics Assisted by Singe port

Countries

Venezuela

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 5, 2021Actual

Primary Completion Date

Jun 5, 2023Estimated

Completion Date

Dec 5, 2023Estimated

First Submitted Date

Jun 8, 2021

First Submission Date that Met QC Criteria

Jun 15, 2021

First Posted Date

Jun 18, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 15, 2021

Last Update Posted Date

Jun 18, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Guillermo Borjas, Director, Unidad Internacional de Cirugia Bariatrica y MetabolicaPrincipal Investigator

Lead Sponsor

Unidad Internacional de Cirugia Bariatrica y MetabolicaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

New approach for Nissen Sleeve Gastrectomy by single port using double magnetic system

Detailed Description

A bariatric surgery is performed for weight loss and esophagogastric reflux, called Nissen Sleeve, in which a new approach is used which is the only port that helps to shorten the hospital stay because it decreases postoperative pain as well as increases the esthetic Ad benefit. In addition, a system of magnets is used to assist in different steps of the surgery for the correct retraction of the tissues and to be able to suture or perform the correct dissection.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
N-Sleve patients		Patient that were selected for surgery	Other: Magnetics Assisted by Singe port

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Magnetics Assisted by Singe port	Other	Use of magnet for assistance through the surgery, and a novel approach as it is single port	N-Sleve patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Surgical Complications	any adverse event during the surgery	1 month
Surgical time	how long does the surgery take	30 minutes
Weight loss follow up	Kg that the patient loss	1 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Any patient with controlled comorbidities suffering from obesity and GERD.

Exclusion Criteria:

Patients with pacemakers, psychiatric problems or uncontrolled metabolic diseases

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Patients from the UICBM from Venezuela-Colombia

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Guillermo Borjas, M.D.	Contact	4146863041		MaldonadoAndres94@gmail.com

Overall Officials

Name	Affiliation	Role
Andres Maldonado, M.D.	UICBM	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Unidad Internacional de Cirugia Bariatric y Metabolica	Recruiting	Maracaibo	Zulia	4002	Venezuela

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity
D005764	Gastroesophageal Reflux

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided